Certificate of Analysis
CAS No.: 103-90-2 EINECS No.: 203-157-5
NO.:TW-08-055
|
Product name |
Acetaminophen |
|
||||||||
|
Batch NO. |
1508023006 |
Packing |
25kg / fibre drum |
|
||||||
|
MFG. Date |
2015.8.23 |
Quantity |
1006Kg |
|
||||||
|
EXP. Date |
2019.8.21 |
Analysis Date |
2015.8.26 |
|
||||||
|
Standard |
USP35 |
|
||||||||
|
Contents |
Specification |
Results |
|
|||||||
|
Characters |
White crystalline powder |
Conforms |
|
|||||||
|
Identification |
IR,UV,TLC Complies with the test for identification |
Conforms |
|
|||||||
|
Melting point |
168-172℃ |
169.3-170.0℃ |
|
|||||||
|
Loss on drying |
≤0.5% |
0.09% |
|
|||||||
|
Residue on ignition |
≤0.1% |
0.05% |
|
|||||||
|
Chloride |
≤0.014% |
≤0.014% |
|
|||||||
|
Sulfate |
≤0.02% |
≤0.02% |
|
|||||||
|
Sulfide |
Conforms |
Conforms |
|
|||||||
|
Heavymetals |
≤0.001% |
≤0.001% |
|
|||||||
|
Readily arbonizable substances |
Conforms |
Conforms |
|
|||||||
|
Free p-aminophenol |
≤0.005% |
≤0.005% |
|
|||||||
|
Limit of p-chloroacetanilide |
≤0.001% |
≤0.001% |
|
|||||||
|
Organic volatile impurities |
Conforms |
Conforms |
||||||||
|
Assay |
98.0%-101.0% |
99.72% |
||||||||
|
Conclusion: It complies with the requirements of the USP35 |
|
|||||||||
|
Approved by |
Yang Jing yu |
Checked by |
Zhu zhi mei |
Analyzed by |
Yang lian |
|
||||